We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Seasonal Allergic Rhinitis Study (SAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01123252
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : August 23, 2012
Information provided by:

Study Description
Brief Summary:
The study aims to examine the effect of probiotics on the clinical symptoms of allergic rhinitis and to elucidate some of the immunological mechanisms involved.

Condition or disease Intervention/treatment Phase
Seasonal Affective Rhinitis Asthma Grass Allergy Dietary Supplement: Lactobacillus casei Shirota (LcS) Dietary Supplement: Placebo Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effect of Yoghurt-type Drink on Symptoms of Subjects Suffering Seasonal Allergic Rhinitis (SAR) [Rhinitis 2]
Study Start Date : September 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Seasonal Affective Rhinitis Group 1
Active Comparator Group
Dietary Supplement: Lactobacillus casei Shirota (LcS)
Subjects will receive one bottle of Yakult containing the probiotic bacterium Lactobacillus casei Shirota (active drink) once daily for 4 months (16 weeks).
Other Name: Yakult fermented milk
Placebo Comparator: Seasonal Affective Rhinitis Group 2
Placebo Group
Dietary Supplement: Placebo
Subjects will receive one bottle of a placebo milk drink, once daily for 4 months (16 weeks).

Outcome Measures

Primary Outcome Measures :
  1. Total nasal symptom score [ Time Frame: 10 minutes following nasal allergen challenge ]

    Following exposure to allergen, there is an immediate rise in the reported symptoms,the recording of the symptoms scored at various time points is referred to as the TNSS. Participants will be asked to record their symptoms on a 4 point scale, with 0 representing no symptoms and 3 representing maximal symptoms:

    0 = absent symptoms

    1. = mild symptoms
    2. = moderate symptoms
    3. = severe symptoms

    Symptoms will be recorded under the following: Sneezing / Itching / Rhinorrhoea / Congestion

    The individual symptoms will be summed to give a total nasal symptom score.

Secondary Outcome Measures :
  1. Area under the curve for nasal symptoms scores for 12 hours following nasal allergen challenge [ Time Frame: 12 hours ]
  2. • Area under the curve for peak nasal inspiratory flow for 12 hours following nasal allergen challenge [ Time Frame: 12 hours ]
  3. Phenotype of nasal epithelial cells from scrapings [ Time Frame: 4 months ]
  4. Nasal lavage inflammatory mediator profile [ Time Frame: 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women over 16 years of age.
  • A history of SAR for a minimum of 2 years before study entry.
  • Documentation of sensitivity by positive skin testing (by prick or intradermal methods) or by adequately validated in vitro tests for specific IgE (e.g., RAST, PRIST) to grass pollen within 12 months prior to enrolment. If this is not available, appropriate tests will be performed at screening.
  • Able to provide written informed consent

Exclusion Criteria:

  • Ingestion of probiotics as part of normal diet
  • Significant medical, surgical or psychiatric disease that in the opinion of the participants' attending physician would affect subject safety or influence the study outcome.
  • Symptoms of rhinitis at screening indicated by total symptom scores of more than 2 out of 12 (based on a combination of nasal symptoms of blockage, sneezing, rhinorrhoea and itching).
  • Current smokers or ex-smokers of <1 year or those who have smoked the equivalent of 20 cigarettes/day for 20 years or more.
  • Participants receiving any form of corticosteriod from 1 month prior to the study
  • Inadequate washout periods for the following:

Intranasal cromolyn (2 weeks) Intranasal or systemic decongestants (3 days) Intranasal or systemic antihistamines (3 days), except astemizole (6 weeks) or loratadine (10 days).

  • Documented evidence of acute or significant chronic sinusitis
  • A history of hypersensitivity to the milk or its products
  • Pregnant women or those planning a pregnancy. It is important not to include pregnant women in the study due to the possibility of miscarriage following anaphylaxis.
  • Lactating women are excluded as those infants breast fed by mothers responding to allergenic challenges can transmit the manifestations of allergic responses to the feeding infant via breast milk
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123252

United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
CRTU University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
Sponsors and Collaborators
University of East Anglia
Quadram Institute
Norfolk and Norwich University Hospitals NHS Foundation Trust
Yakult Honsha Co., LTD
Principal Investigator: Andrew Wilson University of East Anglia
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Andrew Wilson, University of East Anglia
ClinicalTrials.gov Identifier: NCT01123252     History of Changes
Other Study ID Numbers: UEA SAR 1
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by University of East Anglia:
Lactobacillus casei

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases